Opposing disk device for grasping cardiac valve tissue

ABSTRACT

The present disclosure relates to repair devices and methods for repair of regurgitant tricuspid valves. A repair method includes positioning a repair device at a tricuspid valve in a collapsed configuration. The repair device includes a proximal grasping assembly movable between a first position and a second position and a distal grasping assembly movable between a third position and a fourth position. An actuator rod operatively connected to each of the proximal grasping assembly and the distal grasping assembly so that distal movement of the actuator rod moves the proximal grasping assembly proximally and the distal grasping assembly distally.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/519,635, filed Jul. 23, 2019, that is a continuation of U.S. patentapplication Ser. No. 15/349,288, filed Nov. 11, 2016, now U.S. Pat. No.10,398,553, the entire contents of which are incorporated herein by thisreference.

BACKGROUND

The tricuspid valve controls blood flow from the right atrium to theright ventricle of the heart, preventing blood from flowing backwardsfrom the right ventricle into the right atrium so that it is insteadforced through the pulmonary valve and into the pulmonary arteries fordelivery to the lungs. A properly functioning tricuspid valve opens andcloses to enable blood flow in one direction. However, in somecircumstances the tricuspid valve is unable to close properly, allowingblood to regurgitate back into the atrium. Such regurgitation can resultin shortness of breath, fatigue, heart arrhythmias, and even heartfailure.

Tricuspid valve regurgitation has several causes. Functional tricuspidvalve regurgitation (FTR) is characterized by structurally normaltricuspid valve leaflets that are nevertheless unable to properly coaptwith one another to close properly due to other structural deformationsof surrounding heart structures. Often, the right ventricle is dilatedas a result of pulmonary hypertension or an abnormal heart musclecondition (cardiomyopathy).

Other causes of tricuspid valve regurgitation are related to defects ofthe tricuspid valve leaflets, tricuspid valve annulus, or othertricuspid valve tissues. In some circumstances, tricuspid valveregurgitation is a result of infective endocarditis, blunt chest trauma,rheumatic fever, Marfan syndrome, carcinoid syndrome, or congenitaldefects to the structure of the heart. Tricuspid valve conditions arealso often associated with problems related to the left side of theheart, such as mitral valve regurgitation.

Tricuspid valve regurgitation is often treated by replacing thetricuspid valve with a replacement valve implant or by repairing thevalve through an interventional procedure. However, issues can ariserelated to deployment and effectiveness of various treatment options.For instance, properly positioning and aligning a repair device withrespect to the tricuspid valve can be difficult, particularlyconsidering that the valve leaflets and other structures arecontinuously moving within the dynamic cardiac environment.

The subject matter claimed herein is not limited to embodiments thatsolve any disadvantages or that operate only in environments such asthose described above. Rather, this background is only provided toillustrate one exemplary technology area where some embodimentsdescribed herein may be practiced.

BRIEF SUMMARY

Certain embodiments described herein are directed to devices and methodsfor repairing tissue, such as tissue of a malfunctioning cardiac valve,including a regurgitant tricuspid valve. In some embodiments, a methodfor repairing a targeted cardiac valve includes positioning and/ordelivering a repair device, which is passable between a collapsedconfiguration and an expanded configuration, at a targeted cardiacvalve, such as a regurgitant tricuspid valve. In some embodiments, therepair device includes a proximal disk, a distal disk spaced apart fromthe proximal disk so as to define a grasping space therebetween forgrasping cardiac valve tissue, and a neck section joining the proximaldisk and the distal disk, the neck section having a diameter that issmaller than a diameter of the proximal disk and the distal disk.

In certain embodiments, the distal disk is then deployed on a first sideof the targeted cardiac valve by passing the distal disk from thecollapsed configuration to the expanded configuration. The proximal diskis then deployed on a second side of the targeted cardiac valve bypassing the proximal disk from the collapsed configuration to theexpanded configuration so as to grasp the targeted cardiac valve tissue(e.g., tricuspid valve leaflets) between the deployed distal disk andthe deployed proximal disk.

In some embodiments, deployment of the proximal disk simultaneouslycaptures the three leaflets of the tricuspid valve between the proximaldisk and the distal disk. In some embodiments, the grasping space issized and shaped to conform to an anatomical shape of the targetedtricuspid valve leaflets. In certain embodiments, the repair deviceincludes a plurality of grip elements configured to enhance engagementof the repair device with the targeted cardiac valve tissue upondeployment of the repair device. In some embodiments, the grip elementsare disposed on the proximal disk at an area of the proximal disk facingthe distal disk, and are disposed on the distal disk at an area of thedistal disk facing the proximal disk. In some embodiments, the repairdevice includes a wireframe structure formed from asuperelastic/shape-memory material, such as nitinol.

In some embodiments, the repair device is delivered to a targetedcardiac valve through a transjugular approach. In some embodiments,prior to deployment, the distal disk and the proximal disk aremaintained in the collapsed configuration by a sheath, and wherein thedistal disk and the proximal disk are passed to respective expandedconfigurations by unsheathing the distal section and the proximalsection. In some embodiments, the distal disk is deployed on aventricular side of the targeted valve, and wherein the proximal disk isdeployed on an atrial side of the targeted valve.

In some embodiments, an interventional device configured for repair of aregurgitant tricuspid valve includes a proximal disk passable between acollapsed configuration and an expanded configuration; a distal diskpassable between a collapsed configuration and an expandedconfiguration, the distal disk being spaced apart from the proximal diskso as to define a grasping space therebetween for grasping tricuspidvalve leaflets when the proximal disk and the distal disk are inexpanded configurations and are deployed at a tricuspid valve; and aneck section joining the proximal disk and the distal disk, the necksection having a diameter that is smaller than a diameter of theproximal disk and the distal disk.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of the invention can be obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof which areillustrated in the appended drawings. Understanding that these drawingsdepict only typical embodiments of the invention and are not thereforeto be considered to be limiting of its scope, the invention will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIG. 1 illustrates a human heart showing normal blood flow paths;

FIG. 2 illustrates a superior view of a normally functioning tricuspidvalve in a closed position;

FIG. 3 illustrates a superior view of a tricuspid valve in an openposition;

FIG. 4 illustrates a superior view of a malfunctioning tricuspid valveunable to properly close;

FIG. 5 illustrates an exemplary embodiment of a repair device that maybe utilized to perform a tricuspid repair procedure as described herein;

FIGS. 6-9 illustrate delivery and deployment of the repair device in atricuspid repair procedure, showing deployment of the repair devicethrough a delivery system so as to grasp leaflet tissue in a deployedposition;

FIG. 10 illustrates a superior view of a tricuspid valve showing therepair device in a deployed position;

FIGS. 11 and 12 illustrate another embodiment of a repair deviceincluding grasping elements attached to a central shaft with a hingedattachment;

FIGS. 13 and 14 illustrate an embodiment of a repair device having anactuation mechanism controllable by translation of an actuation rod;

FIGS. 15 and 16 illustrate an embodiment of a locking mechanism that maybe utilized during deployment of a repair device, enabling release andrepositioning of the repair device; and

FIGS. 17 and 18 illustrate another embodiment of a locking mechanismthat may be utilized during deployment of a repair device, enablingrelease and repositioning of the repair device.

DETAILED DESCRIPTION

At least some of the embodiments described herein are directed todevices and methods for repairing a malfunctioning cardiac valve, suchas a regurgitant tricuspid valve. Some embodiments are directed todevices and methods configured to provide repair of a regurgitanttricuspid valve utilizing an opposing disk repair device configured forgrasping and fixing the three leaflets of the tricuspid valve togetherin a desired configuration to improve valve closure and minimize oreliminate regurgitation at the tricuspid valve.

Although many of the examples illustrated and described herein aredirected to tricuspid valve regurgitation, it will be understood thatthe principles, features, and components described herein may also beapplied in other applications, such as repair of other heart valves, oruse in other interventional procedures or treatment applications.

FIG. 1 illustrates a cross-sectional view of a heart 10 showing a normalblood flow path through the heart. Deoxygenated blood enters the rightatrium 16 through the superior vena cava 14 and superior vena cava 12.During diastole, suction from expansion of the right ventricle 20 andpressure from contraction of the right atrium 16 forces blood from theright atrium 16 across the tricuspid valve 18 and into the rightventricle 20. During ventricular systole, blood is then forced from theright ventricle 20 through the pulmonary valve 22 and into the pulmonaryarteries for delivery to the lungs. In a normally functioning heart, thetricuspid valve 18 closes during systole to prevent backwards movementof blood from the right ventricle 20 back into the right atrium 16. Whena tricuspid valve is not functioning properly, it may fail to fullyclose such that some of the blood passes back across the tricuspid valve18 and into the right atrium 16, rather than through the pulmonary valve22.

Oxygenated blood returning from the lungs enters the left atrium 24,where it is then passed through the mitral valve 26 and into the leftventricle 28. During ventricular systole, the blood is then passed fromthe left ventricle through the aortic valve for delivery throughout thebody. Similar to the right side of the heart, failure of the mitralvalve 26 to fully close during ventricular systole leads toregurgitation of blood from the left ventricle 28 back into the leftatrium 24. In some circumstances, problems related to mitral valveregurgitation or other issues with the left side of the heart also causeor are associated with structural issues on the right side of the heart,such as tricuspid valve regurgitation.

FIGS. 2-4 illustrate superior views of a tricuspid valve 18 in variousstates and positions. FIG. 2 illustrates a properly functioningtricuspid valve 18 in a closed position. A properly functioningtricuspid valve 18 takes this form during ventricular systole in orderto block backflow of blood. As shown, when in the closed position, thethree leaflets of the tricuspid valve 18 coapt to fully close the valve.FIG. 3 illustrates a properly functioning tricuspid valve 18 in an openposition. When open, the leaflets of the tricuspid valve 18 extenddownward into the right ventricle so that passage of blood through thetricuspid valve 18 is provided.

FIG. 4 illustrates a defective tricuspid valve 18 during ventricularsystole. In contrast to the properly closed tricuspid valve of FIG. 2,the leaflets of the defective tricuspid valve are unable to fully coapt,leaving a passage through which regurgitant blood may pass. Theinability to fully close may be due to defects to the leafletsthemselves, or to defects to other structures of the heart which deformthe tricuspid valve annulus or stretch the chordae tendineae, forexample.

FIG. 5 illustrates an embodiment of a repair device 100 that may beutilized to reduce or eliminate regurgitation in a defective valve, suchas a regurgitant tricuspid valve. The illustrated embodiment has aproximal end 102 and a distal end 104. As shown, a proximal disk 108 isdisposed opposite a distal disk 110, with the proximal disk 108 disposedtoward the proximal end 102 and the distal disk 110 disposed toward thedistal end 104. The proximal disk 108 and the distal disk 110 are joinedby a neck section 106. As shown, the neck section 106 has a smallerdiameter than the adjoining disks 108 and 110. In some embodiments, aratio of a diameter of the neck section 106 to a diameter of one or bothof the disks 108 and 110 is about 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, or 0.6,or is within a range having endpoints defined by any two of theforegoing values.

Although the exemplary embodiment illustrated here includes disk-shapedmembers 108 and 110, it will be understood that similar components andprinciples described herein may be applied to embodiments having membersof other shapes. For example, some embodiments may include elementshaving a polygonal profile, as opposed to a rounded disk profile. Insome embodiments, a polygonal profile can aid in the flexure performanceand/or the folding and unfolding functionality of the repair device.

The proximal disk 108 and distal disk 110 are positioned relative to oneanother to define a grasping space therebetween. When deployed, therepair device 100 is positioned so as to grasp valve leaflets betweenthe proximal disk 108 and the distal disk 110. In some embodiments, therepair device 100 is configured such that the size and shape of thegrasping space between the disks 108 and 110 matches targeted tricuspidvalve anatomy. For example, a distance between the proximal disk 108 andthe distal disk 110 may be sized as approximately the same thickness oftargeted tricuspid valve leaflets or slightly smaller than the thicknessof the leaflets so as to provide sufficient engagement of the repairdevice 100 with the leaflets.

In the illustrated embodiment, the neck section 106 is positioned tojoin the opposing disks 108 and 110 at the center of each opposing disk108 and 110. In other embodiments, a neck section is offset from thecenter of one or both opposing disks. In the illustrated embodiment, theproximal disk 108 and the distal disk 110 are substantially the same insize and shape. In other embodiments, a disk may have a differentlyconfigured size and/or shape than the opposite disk. For example, repairdevice having an offset neck section and/or having differently sizeddisks may be utilized in applications where a targeted valve has uniqueanatomy, in circumstances where particular regions of a targeted valverequire greater coverage and/or grasping surface area, and/or in otherimplementations where a non-symmetrical configuration can provideinterventional benefits.

The illustrated embodiment also includes a plurality of grip elements112 extending from the opposing disks 108 and 110. The grip elements 112may be configured as tines, barbs, ridges, or other structures forenhancing engagement of the repair device 100 with targeted tissuegrasped between the opposing disks 108 and 110 when the repair device isdeployed. In the illustrated embodiment, each of the opposing disks 108and 110 include grip elements 112 positioned so as to face and/or extendtoward the opposite disk in the grasping space. In other embodiments,grip elements may be omitted, or may be included on some sections of thedevice and omitted on others (e.g., included on one disk but not theopposite disk and/or included at only portions of a disk).

The illustrated embodiment also includes a connection element 114configured to enable connection of the repair device 100 to one or moreseparate interventional tools, such as a delivery catheter or deliveryrod, as explained in more detail below. In some embodiments, the repairdevice 100 includes a wireframe structure enabling the repair device 100to be moved between a collapsed configuration and an expanded/deployedconfiguration. In some embodiments, the repair device 100 is formed froma superelastic/shape-memory material, such as nitinol, enabling thedevice to be compressed into the collapsed configuration (e.g., fortranscatheter delivery) without plastic deformation so that it mayreturn to the expanded configuration upon deployment.

In the illustrated embodiment, the opposing disks 108 and 110 areconfigured so that the opposing gripping surfaces are substantiallyparallel with one another. In other embodiments, one or both disks maybe shaped so as to provide a gripping surface with a tapering and/ornon-linear profile. For example, along a path from a radially centrallocation of a gripping surface (e.g., near the neck section) movingtoward the periphery, the corresponding disk may be shaped such that thegripping surface tapers further toward or further away from the opposinggripping Such a configuration may be utilized to better match the shapeof targeted valve tissue (e.g., leaflets), to provide better engagementonce deployed, and/or to conform to unique anatomy of a particularpatient, for example.

FIGS. 6-9 illustrate a system and method of delivering and deploying therepair device 100 at a targeted tricuspid valve 18 to repair thetricuspid valve 18 and reduce or eliminate regurgitation through thevalve 18. FIG. 6 illustrates the repair device 100 in a collapsedconfiguration within a delivery system. The delivery system includes adelivery catheter 202 positioned within a sheath 200. As shown, theconnection element 114 of the repair device 100 is coupled to aconnection element 204 of the delivery catheter 202 at a distal portionof the delivery catheter 202. The connection elements 204 and 114 aredetachably engaged with one another through a mechanical linkage (e.g.,one or more clips, pins, threaded engagements, tabs, slots, or otherfastener components), magnetic linkage, and/or other fastening means.

In the illustrated embodiment, the delivery catheter 202 is translatablerelative to the sheath 200 so that the repair device 100 may bepositioned relative to the sheath 200 through translation of thedelivery catheter 202.

As depicted in FIG. 6, the distal end of the delivery system is passedfrom a position in the right atrium, superior to the tricuspid valve 18,past the tricuspid valve so as to extend into the right ventricle. Forexample, the delivery system may be routed to the tricuspid valve 18through a transjugular approach through the superior vena cava and intothe right atrium. Alternatively, the delivery system may be routed tothe targeted valve through a transfemoral approach, transapicalapproach, or other approach. As shown, the delivery system is positionedso that the distal end of the repair device 100 extends past thetricuspid valve 18 and into the right ventricle, while the proximal endof the repair device 100 remains on the atrial side of the valve 18.

From this position, the sheath 200 may be partially retracted so as toallow the distal section of the repair device 100 to expand to deploythe distal disk 110 on the ventricular side of the valve 18, as shown inFIG. 7. Although the illustrated embodiment shows deployment as a resultof proximal retraction of the sheath 200 relative to the deliverycatheter 202 and the repair device 100, alternative implementations maydeploy the repair device 100 by distally pushing the delivery catheter202 relative to the sheath 200 or through a combination of distallypushing the delivery catheter 202 and proximally retracting the sheath200.

As shown in FIG. 8, continued retraction of the sheath 200 relative tothe delivery catheter 202 and the repair device 100 allows the proximalsection of the repair device 100 to expand so as to deploy the proximaldisk 108 on the atrial side of the valve 18. As the proximal disk 108deploys, the leaflets of the tricuspid valve 18 are fixed between theopposing disks 108 and 110, enabling the repair device 100 to maintainthe captured leaflets in a position that reduces or eliminatesregurgitation through the valve 18.

In some implementations, the repair device 100 may be selectivelyretracted by re-sheathing the proximal disk 108. For example, to adjustthe positioning of the repair device 100 relative to the leaflets of thevalve 18 and/or to attempt a better grasping of leaflets, the proximaldisk 108 may be pulled back into the sheath 200 (and/or the sheath 200may be pushed over the proximal disk 108), placing the device back intothe configuration shown in FIG. 7. The device may then be readjusted orrepositioned before re-deploying the proximal sheath 108 to grasp theleaflets again. In some circumstances, the repair device 100 may befully retracted back to the configuration shown in FIG. 6. For example,the repair device 100 may be fully retracted if a procedure is abortedor if further monitoring or analysis is required.

As shown in FIG. 9, after the repair device 100 has been deployed tograsp the leaflets of the valve 18, the delivery catheter 202 may bedecoupled from the connection element 114, and the sheath 200 anddelivery catheter 202 may be removed from the treatment site. The repairdevice 100 remains in position with the leaflets fixed to minimize oreliminate regurgitation through the valve 18. As shown, thecorresponding connecting elements 114 and 204 are decoupled from oneanother to enable detaching of the repair device 100 from the remainderof the delivery system. The connecting elements 114 and 204 may bedecoupled by actuating a mechanical linkage to disconnect the respectiveelements (e.g., unclasping, unscrewing, removing tabs from slots, and/orother means of detaching a mechanical fastening), uncoupling a magneticconnection, or otherwise disengaging the connection elements 114 and204.

Although the example depicted in FIGS. 6-9 illustrate an approach inwhich the repair device 100 is routed to the valve 18 from a positionsuperior prior to deployment (e.g., through a transjugular approach), itwill be understood that the described principles and features may beapplied to other approaches as well. For example, in a transapicalapproach, the repair device 100 may be inserted into the right ventricleand then be passed from a position inferior to the tricuspid valvethrough the valve and into a position superior to the valve. In theillustrated implementation, the repair device 100 is deployed by firstdeploying the distal disk 110 on the inferior (ventricular) side of thevalve 18, and then further deploying the proximal disk on the superior(atrial) side of the valve 18. It will be understood that from aninferior approach, the repair device 100 may be deployed by firstdeploying the distal disk 110 on the superior (atrial) side of thevalve, and then deploying the proximal disk on the inferior(ventricular) side of the valve.

FIG. 10 illustrates a superior view of the tricuspid valve 18 showingthe repair device 100 in a deployed state and showing the proximal disk108 oriented on the atrial side of the valve 18. As shown, the opposingdisks of the repair device 100 beneficially grasp and fix the threeleaflets of the tricuspid valve 18. At least some of the embodimentsdescribed herein are able to provide simultaneous grasping of all threeof the tricuspid leaflets, offering the advantage of a straightforwarddeployment process uncomplicated by the need to make multiple graspingmaneuvers to properly engage with all three of the tricuspid valveleaflets.

For example, during a valve repair procedure, it can often be difficultto properly position a repair device relative to the targeted siteand/or to grasp targeted leaflets because the position of the leafletsand other tissues are in dynamic flux. In particular, the challenge iscompounded for repair procedures related to the tricuspid valve, wherethere are three separate leaflets within the treatment environment. Oneor more of the embodiments described herein enable simultaneous graspingof all three leaflets, enhancing the likelihood of successfuldeployment, lowering the number of readjustment maneuvers, and reducingprocedure time, for example.

Further, less positional accuracy of the device prior to deployment isrequired as a result of the relatively wide profile of the opposingdisks. The opposing disks function to broaden the acceptable range ofdeployment positions capable of successfully grasping all three leafletsin a manner that sufficiently treats the regurgitant condition. Asdescribed, positioning and orienting a delivery system prior todeployment can be challenging due to the dynamic nature of the treatmentenvironment. A more forgiving positioning requirement allows for fasterprocedures and less need for multiple grasping attempts, for example.

FIGS. 11 and 12 illustrate another embodiment of a repair device 300which can be utilized in a cardiac valve repair procedure, such as aregurgitant tricuspid valve repair procedure. FIG. 11 illustrates atop/plan view of the device 300 and FIG. 12 illustrates a front view ofthe device 300. As shown by FIG. 12, the repair device 300, whendeployed, includes a profile configured to aid in flexing between acollapsed configuration and an expanded configuration. In theillustrated embodiment, the disks/disk-like members of the device 300include three separate proximal grasping elements 316 and three separatedistal grasping elements 318. Other embodiments may include one or bothsides (proximal and/or distal) having two grasping elements, or morethan three grasping elements.

In the illustrated embodiment, the grasping elements 316 and 318 aresubstantially aligned so that each corresponding pair is capable ofgrasping leaflet tissue between the pair. In alternative embodiments,one or more of the proximal grasping elements 316 may be offset from thedistal grasping elements 318, or vice versa. Some embodiments may omitgrasping elements at certain sections of the device. For example, someembodiments may include a distal section formed as a disk (such asdistal section 110 of repair device 100 described above), and include aproximal section having grasping elements 316. Likewise, someembodiments may include a distal section having grasping elements 318,and include a proximal section formed as a disk (such as proximalsection 108 of repair device 100 described above).

The grasping elements 316 and 318 may be symmetrically arranged about acentral shaft 306 (which includes a neck section between the graspingelements), as shown. Alternatively, one or more grasping elements 316,318 may be offset to form an asymmetric arrangement. The graspingelements 316, 318 may be sized for different anatomical and/orprocedural needs. For example, different grasping elements 316, 318 maybe sized according to the tricuspid valve leaflets of a particularpatient in order to provide a desired level of leaflet constraint whendeployed.

In some embodiments, the repair device 300 is formed as a wireframestructure, such as a wireframe structure of nitinol. Alternatively, oneor more sections, such as the grasping elements 316 and/or 318, may beformed as separate structures, such as solid sections of polymer,stainless steel, nitinol, cobalt-chromium alloy, other suitablematerials, or combinations thereof. As shown, the grasping elements 316,318 may include one or more grip elements 312, which may be configuredsimilar to the grip elements 112 of the repair device 112 illustrated inFIG. 5.

In the illustrated embodiment, the grasping elements 316 and 318 areformed as fan-shaped elements that continuously broaden as they extendfrom the central shaft 306 to their perimeters. Alternative embodimentsmay include one or more grasping elements having different shapes, suchas extensions that do not broaden or that broaden in a discontinuousfashion, such as only at a perimeter section. As shown, the graspingelements 316 and 318 are configured so as to make up about half of theplan view surface area of the device. For example, as best shown by theplan view of FIG. 11, the grasping elements 316 make up about as much ofthe plan view surface area as do the spaces in between each of thegrasping elements 316 (e.g., considering the plan view surface area tobe defined by a circle circumscribing the plan view of the device). Inother embodiments, the grasping elements may be configured to make upabout 20%, 40%, 60%, or 80% of the plan view surface area of the device,or to make up an amount of plan view surface area within a range definedby any two of the foregoing values.

In the illustrated embodiment, the grasping sections 316 and 318 areconnected to the central shaft 306. Beneficially, the central shaft 306functions as a hinge point for the separate grasping sections 316 and318, enabling the grasping sections to flex according to the movement ofgrasped valve leaflets after the repair device 300 has been deployedwithin a cardiac valve. In some implementations, the separate graspingsections 316, 318 are able to independently flex at the respective hingepoints of the central axis 306 so as to independently provide the neededflexure at each particular grasping section 316 (e.g., to providedifferent flexure for each of the separate tricuspid valve leaflets).

FIG. 12 shows the repair device 300 showing the grasping elements 316and 318 moving from a neutral position into an exemplary flexedposition. For example, tricuspid valve leaflets will move somewhatdownward (i.e., towards the right ventricle) to open the valve duringdiastole, and will then move upward (i.e., toward the right atrium) tocoapt with one another and close the valve during systole. The flexprovided by the repair device 300 allows the leaflets to move and/orcoapt with one another without being overly constrained.

In some embodiments, the central shaft 306 and the grasping elements316, 318 are integrally joined, and the central shaft 306 functions as ahinge as a result of the inherent flexibility and resiliency of thejoint formed by the central shaft 306 and the grasping elements 316,318. In other embodiments, one or more grasping elements are coupled tothe central shaft 306 by a mechanical hinge that enables proximal and/ordistal rotation of the corresponding grasping element.

Delivery and deployment of the repair device 300 may be carried out in amanner similar to the process illustrated in FIGS. 6 to 9, by retractinga sheath and/or pushing a delivery catheter so as to allow the device toexpand into a deployed state. Accordingly, the delivery systemillustrated in FIGS. 6 to 9 may be utilized to deliver the repair device300, or any other interventional repair devices described herein. Insome embodiments, the central shaft 306 may include and/or may functionas a connection element for coupling with a delivery catheter such as inFIGS. 6 to 9.

FIG. 13 illustrates an embodiment of a repair device 400 having anactuation mechanism for controlling the actuation of grasping elements416 and 418 about hinge points 420 and 422. The actuation mechanismdescribed herein may be utilized to actuate any of the grasping elementsdescribed herein, such as any of the grasping elements 316, 318described in relation to FIGS. 11 and 12. The repair device 400 may bedelivered using one or more delivery system components illustrated inFIGS. 6 to 9. For example, the central shaft 406 may include and/or mayfunction as a connection element to provide attachment to the deliverycatheter 202.

FIG. 13 illustrates the repair device 400 with the grasping elements 416and 418 in a deployed position, such as they would appear when graspingcardiac valve tissue. As shown, an actuator rod 424 extends through thecentral shaft 406. Proximal legs 426 are pivotably coupled to theactuator rod 424 and are respectively joined to each proximal graspingelement 416. Likewise, distal legs 428 are pivotably coupled to theactuator rod 424 and are respectively joined to each distal graspingelement 418.

FIG. 14 illustrates actuation of the actuation rod 424 to move therepair device into a collapsed configuration, such as one having asmaller profile suitable for delivery to the targeted treatment site, orsuch as one that allows repositioning of the device and/or regrasping oftargeted tissue. As indicated, distal translation of the actuator rod424 relative to the central shaft 406 pushes the distal legs 428 furtherdistally. The distal legs 428 thereby act to pull on the distal graspingelements 418, causing them to rotate about hinge points 422 to rotateaway from central shaft 406 into a position relatively more parallelwith the central shaft 406.

In this embodiment, the mechanism associated with the proximal graspingelements 416 works in a slightly different manner. As shown, distaltranslation of the actuator rod 424 causes the proximal legs 426 to movedistally. Because of the curvature of the proximal legs 426 (shown inthis embodiment as having a proximally-facing concavity or “C” shape),the distal movement of the legs 426 at the point where they connect tothe actuator rod 424 causes the opposite ends, which are joined torespective proximal grasping elements 416, to rotate inwardly toward theactuator rod 424. This inward rotation pushes proximally against theproximal grasping elements, causing them to rotate about hinge points420 to move to a position more parallel to the central shaft 406. In theillustrated embodiment, the proximal grasping elements 416 also includeslots 430 to enable inward movement of the proximal legs 426 as theyrotate inwardly and push proximally against the proximal graspingelements 416.

The illustrated actuation mechanisms beneficially enable an operator toselectively move the grasping elements 416, 418 between an openposition, where the device is free to be repositioned relative totargeted anatomy, and a deployed position, where grasping of the tissuemay be maintained. In contrast to a repair device that relies solely onself-expanding components, which may only provide one attempt at properpositioning and deployment, the illustrated repair device 400 enablesrepeated attempts at deployment and thereby increases the likelihood ofa successful procedure.

FIGS. 15 and 16 illustrate an embodiment of a locking mechanism that maybe utilized with a repair device described herein, such as the repairdevice 400 of FIGS. 13 and 14 (in this illustration, other repair devicecomponents such as a central shaft, grasping elements, and actuationmechanisms, have been removed for clarity). FIG. 15 shows an actuatorrod 524 passed through a series of locking plates 532. The lockingplates 532 include holes allowing passage of the actuator rod 524. InFIG. 15, the locking plates 532 are shown in an open configuration whereplates are positioned so that the holes of the plates are sufficientlyaligned to allow translation of the actuator rod 524. In FIG. 16, thelocking plates 532 are shown in a binding configuration, where theplates are moved to a position where the holes are out of alignment andthe locking plates 532 therefore bind against the actuator rod 524.

The illustrated embodiment also includes a lock control 534. In theillustrated embodiment, the locking plates 532 are biased toward thebinding configuration of FIG. 16. When the lock control 534 is movedproximally from the open configuration of FIG. 15, it no longer pressesagainst the locking plates at abutment points 540 and 542, allowing theplates to move toward the binding configuration of FIG. 16. To unlockthe actuator rod 524, the lock control 534 may be moved distally tore-engage with the abutment points 540 and 542, bending the lockingplates 532 to the open position of FIG. 15. The lock control 534 may bejoined to the abutment points 540 and 542, or may be sized so as tocontact them when translated sufficiently distally.

The lock control 534 may extend proximally through a delivery catheter(such as the delivery catheter shown in FIGS. 6 to 9), or may be coupledto a control line that extends proximally through the catheter, and maybe actuated using a handle or other control mechanism coupled to aproximal end of the delivery catheter. The free ends of the lockingplates 532 (the ends opposite the abutment points 540 and 542) may becoupled to an interior surface of the central shaft through which theactuator rod 524 passes through and is translatable through.Alternatively, the free ends may be attached to the proximal graspingelements, or to some other structure separate from the actuator rod 524.

Alternative embodiments may include one or more locking plates that arebiased toward an open configuration rather than a binding configuration.For example, some embodiments may include locking plates biased towardthe configuration shown in FIG. 15, and locking the actuator rod 524requires pulling the lock control 534 so as to pull the locking platesat abutment points 540 and 542 to move to the binding configuration ofFIG. 16.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount or condition close to the stated amount or conditionthat still performs a desired function or achieves a desired result. Forexample, the terms “approximately,” “about,” and “substantially” mayrefer to an amount or condition that deviates by less than 10%, or byless than 5%, or by less than 1%, or by less than 0.1%, or by less than0.01% from a stated amount or condition.

FIGS. 17 and 18 illustrate another embodiment of a locking mechanismthat may be utilized with any of the repair devices described herein (inthe illustrated embodiment, other repair device components such as acentral shaft, grasping elements, actuation mechanism, etc. have beenremoved for clarity). FIG. 17 illustrates an actuator rod 624 passedthrough a locking plate 632. The locking plate 632 includes a holeallowing passage of the actuator rod 624. In FIG. 17, the locking plate632 is forced, by default, into an angled position by a leaf spring 644.In the angled position, the hole of the locking plate 632 is also angledwith respect to the actuator rod 624, causing the locking plate 632 tobind against the actuator rod 624, effectively locking and preventingtranslation of the actuator rod. In some embodiments, the actuator rod624 includes grooves or channels corresponding to locked positions, thegrooves or channels functioning to enhance the engagement and binding ofthe edge of the hole of the locking plate 632 when it is in the angledposition.

FIG. 18 shows the actuator rod 624 in the unlocked position. As shown, alock control 634 may be moved proximally relative to the leaf spring 644and the actuator rod 624, thereby engaging with and pulling the lockingplate 632 into a position more perpendicular to the longitudinal axis ofthe actuator rod 624. In this position, the locking plate hole throughwhich the actuator rod 624 passes does not bind against the actuator rod624, allowing the actuator rod 624 to freely translate. The lock control634 may extend proximally through a delivery catheter (such as thedelivery catheter shown in FIGS. 6 to 9) or may be coupled to a controlline that extends proximally through the catheter, and may be actuatedusing a handle or other control mechanism coupled to a proximal end ofthe delivery catheter.

In the illustrated embodiment, a holding structure 646 is disposedopposite the lock control 634, and is configured to maintain the lockingplate 632 in position against the leaf spring 644. As shown, the holdingstructure 646 is shaped to define a pivot space 648 to allow one end ofthe locking plate 632 to pivot when the locking plate 632 is moved fromthe angled position to the more perpendicular position.

Elements described in relation to any embodiment depicted and/ordescribed herein may be combinable with elements described in relationto any other embodiment depicted and/or described herein. For example,any element described in relation to a repair device of FIGS. 5 to 10may be combinable with any element described in relation to a repairdevice of FIGS. 11 and 12, an actuation mechanism of FIGS. 13 and 14,and/or a locking mechanism of FIGS. 15 and 16.

The present invention may be embodied in other forms, without departingfrom its spirit or essential characteristics. The described embodimentsare to be considered in all respects only as illustrative and notrestrictive. The scope of the invention is, therefore, indicated by theappended claims rather than by the foregoing description. All changeswhich come within the meaning and range of equivalency of the claims areto be embraced within their scope.

What is claimed is:
 1. An interventional device configured for repair ofa regurgitant tricuspid valve, the repair device comprising: a proximalgrasping assembly movable between a first position and a secondposition; a distal grasping assembly movable between a third positionand a fourth position, the distal grasping assembly being spaced apartfrom the proximal grasping assembly so as to define a grasping spacetherebetween; an actuator rod operatively connected to each of theproximal grasping assembly and the distal grasping assembly; and alocking assembly mounted to the actuator rod, the locking assembly beingconfigured to transition from an open configuration allowing translationof the actuator rod to a binding configuration limiting translation ofthe actuator rod.
 2. The interventional device of claim 1, wherein thelocking assembly comprises a first locking plate and a second lockingplate.
 3. The interventional device of claim 2, wherein the firstlocking plate and the second locking plate are biased toward the bindingconfiguration.
 4. The interventional device of claim 3, wherein thelocking assembly comprises a lock control configured to selectivelyrelease the first locking plate and the second locking plate and allowthe first locking plate and the second locking plate to transition tothe binding configuration.
 5. The interventional device of claim 4,wherein the first locking plate and the second locking plate abut adistal end of the lock control.
 6. The interventional device of claim 5,wherein the first locking plate and the second locking plate furthercomprising holes configured to receive the actuator rod.
 7. Theinterventional device of claim 1, wherein the locking assembly comprisesa first locking plate cooperating with a leaf spring.
 8. Theinterventional device of claim 7, wherein the locking assembly comprisesa pivot space within a lock control, the first locking plate beingconfigured to move within the pivot space from the open configuration tothe binding configuration.
 9. The interventional device of claim 8,further comprising a holding structure defining the pivot space.
 10. Aninterventional device configured for repair of a regurgitant tricuspidvalve, the repair device comprising: a proximal grasping assemblymovable between a first position and a second position; a distalgrasping assembly movable between a third position and a fourthposition, the distal grasping assembly being spaced apart from theproximal grasping assembly so as to define a grasping space therebetweenfor grasping tricuspid valve leaflets when the proximal graspingassembly and the distal grasping assembly are in second position andfourth position, respectively, and are deployed at a tricuspid valve; anactuator rod operatively connected to each of the proximal graspingassembly and the distal grasping assembly so that distal movement of theactuator rod simultaneously moves the proximal grasping assemblyproximally and the distal grasping assembly distally; and a lockingassembly mounted to the actuator rod, the locking assembly beingconfigured to transition from an open configuration allowing translationof the actuator rod to a binding configuration limiting translation ofthe actuator rod.
 11. The interventional device of claim 10, wherein thelocking assembly comprises a first locking plate and a second lockingplate.
 12. The interventional device of claim 11, wherein the firstlocking plate and the second locking plate are biased toward the bindingconfiguration.
 13. The interventional device of claim 12, wherein thelocking assembly comprises a lock control configured to selectivelyrelease the first locking plate and the second locking plate and allowthe first locking plate and the second locking plate to transition tothe binding configuration.
 14. The interventional device of claim 10,wherein the locking assembly comprises a first locking plate cooperatingwith a leaf spring.
 15. The interventional device of claim 14, whereinthe locking assembly comprises a pivot space within a lock control, thefirs locking plate being configured to move within the pivot space fromthe open configuration to the binding configuration.
 16. Aninterventional system configured for repair of a regurgitant tricuspidvalve, the repair system comprising: a delivery system, comprising: asheath; a delivery catheter disposed within the sheath so as to betranslatable within the sheath, the delivery catheter including aconnection element disposed at a distal end of the delivery catheter;and an interventional device, including: a proximal grasping assemblymovable between a pre-deployed position and a deployed position; adistal grasping assembly movable between a pre-deployed position and adeployed position, the distal grasping assembly being spaced apart fromthe proximal grasping assembly so as to define a grasping spacetherebetween for grasping tricuspid valve leaflets when the proximalgrasping assembly and the distal grasping assembly are in deployedpositions and are deployed at a tricuspid valve; an actuator rodoperatively connected to each of the proximal grasping assembly and thedistal grasping assembly so that distal movement of the actuator rodsimultaneously moves the proximal grasping assembly proximally and thedistal grasping assembly distally; and a locking assembly mounted to theactuator rod, the locking assembly being configured to transition froman open configuration allowing translation of the actuator rod to abinding configuration limiting translation of the actuator rod, whereinthe sheath is configured to be retractable relative to the deliverycatheter to expose the interventional device and enable the distalgrasping assembly and the proximal grasping assembly to move toward thedeployed configuration.
 17. The interventional device of claim 16,wherein the locking assembly comprises a first locking plate and asecond locking plate, the first locking plate and the second lockingplate being biased toward the binding configuration.
 18. Theinterventional device of claim 17, wherein the first locking plate andthe second locking plate further comprise holes configured to receivethe actuator rod.
 19. The interventional device of claim 16, wherein thelocking assembly comprises a first locking plate cooperating with a leafspring.
 20. The interventional device of claim 19, wherein the lockingassembly comprises a pivot space defined by a holding structure, thefirst locking plate being configured to move within the pivot space fromthe open configuration to the binding configuration.